AG-Lisdexamfetamine: Uses, Side Effects and Dosage

Serious warnings and precautions box

What AG-Lisdexamfetamine is used for:

AG-Lisdexamfetamine is used to treat:

• Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age or older, adolescents and adults. Treatment with AG-Lisdexamfetamine for ADHD should be combined with other measures, such as psychological counselling, educational and social measures, as part of a total treatment program. AG-Lisdexamfetamine is NOT recommended for use in children with ADHD under 6 years of age.

• Moderate to severe Binge Eating Disorder (BED) in adults. AG-Lisdexamfetamine is NOT recommended for use in children with BED under 18 years of age.

Use of other stimulant medicines for weight loss has been associated with serious heart-related problems. It is not known if AG-Lisdexamfetamine is safe and effective for weight loss.

How AG-Lisdexamfetamine works:

AG-Lisdexamfetamine belongs to a group of medicines called central nervous system stimulants. AG-Lisdexamfetamine is a prodrug, which means that the medicinal ingredient lisdexamfetamine dimesylate is inactive until the body breaks it down into its active form called dextroamphetamine. It works by raising the levels of chemicals in the brain called dopamine and norepinephrine.

• This helps to increase attention and decrease impulsiveness and hyperactivity in patients with ADHD;
• This may help to reduce the number of binge eating days in adults with BED.

The ingredients in AG-Lisdexamfetamine are:

Medicinal ingredient: Lisdexamfetamine dimesylate

Non-medicinal ingredients: Croscarmellose sodium, D&C Yellow No. 10 (30 mg, 70 mg), FD&C Blue No. 1 (40 mg, 50 mg, 60 mg, 70 mg), FD&C Red No. 3 (10 mg, 30 mg, 60 mg, 70 mg), FD&C Red No. 40 (40 mg), gelatin, iron oxide black, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac, strong ammonia solution, titanium dioxide.

AG-Lisdexamfetamine comes in the following dosage forms:

Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg of lisdexamfetamine dimesylate.

Do not use AG-Lisdexamfetamine if:

• you are allergic to amphetamines, the medicinal ingredient lisdexamfetamine dimesylate or its active form (i.e., dextroamphetamine), or any of the other ingredients in AG-Lisdexamfetamine.
• you are sensitive to, allergic to or had a reaction to other stimulant medicines.
• you have advanced arteriosclerosis (hardened arteries).
• you have symptoms of heart disease.
• you have moderate to severe high blood pressure.
• you are agitated.
• you have glaucoma (an eye disease with increased pressure in the eye).
• you have hyperthyroidism (an overactive thyroid gland).
• you have a condition called pheochromocytoma (a rare tumour that usually grows in the adrenal glands, above your kidneys).
• you are taking or have recently taken (in the past 14 days) any medications from the group called monoamine oxidase inhibitors (MAOIs).
• you have a history of drug abuse.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Lisdexamfetamine. Talk about any health conditions or problems you may have, including if you:

• have structural heart abnormalities, cardiomyopathy, serious heart rhythm abnormalities or other serious heart problems.
• have a family history of sudden cardiac death or death related to heart problems.
• have mild high blood pressure.
• do strenuous exercise.

• have a history of seizures (convulsions, epilepsy) or have had abnormal brainwave tests (electroencephalogram; EEGs). • have or have a family history of tics (movements or sounds that you cannot control) or

  Tourette’s syndrome.

• take other medications for ADHD.
• take blood pressure medications or other medicines that can affect blood pressure.

• have or have a family history of mental health problems, including:

  • psychosis,
  • mania,
  • bipolar disorder,
  • depression, or
  • suicide.
• have severe kidney problems, including if you are undergoing dialysis.
• have a history of drug abuse or alcoholism.
• are pregnant, think you are pregnant or are planning to become pregnant.
• are breastfeeding or plan to breastfeed.

Other warnings you should know about:

Dependence and tolerance:

• Amphetamines, such as AG-Lisdexamfetamine, have the potential to cause drug abuse and misuse.
• Abuse of amphetamines can lead to dependence, tolerance, social disorders and possibly serious heart problems and death.

• Long-term misuse of amphetamines may cause:

  • skin diseases;
  • sleeping problems;
  • personality changes;
  • anxious and distressful feelings;
  • rash, uncontrolled behaviour;
  • psychosis;
  • schizophrenia.

• Healthcare professional supervision is needed when you stop taking AG-Lisdexamfetamine. Suddenly ending treatment when taking higher doses of AG-Lisdexamfetamine for a long period of time can cause:

  • extreme fatigue;
  • depression;
  • changes in sleep patterns.
• AG-Lisdexamfetamine should only be given under close medical supervision to patients whose condition has been properly diagnosed.

Driving and using machines: AG-Lisdexamfetamine can affect your ability to drive and use tools or machinery. You should not drive or use tools or machinery until you know how you respond to AG-Lisdexamfetamine.

Pregnancy and breastfeeding:

• Taking AG-Lisdexamfetamine during pregnancy can harm your unborn baby. It should not be used during pregnancy unless your healthcare professional has determined the potential benefits outweigh the potential risks to your baby. Your healthcare professional will discuss these risks with you. If you discover that you are pregnant while taking AG-Lisdexamfetamine, tell your healthcare professional right away.
• AG-Lisdexamfetamine can pass through your breast milk and may harm your baby. You should consult with your healthcare professional to determine if you should stop breastfeeding or discontinue AG-Lisdexamfetamine.

The following have been reported with use of medicines used to treat ADHD such as AG-Lisdexamfetamine:

Growth in children: Slower growth (in weight and / or height) has been reported with the use of lisdexamfetamine dimesylate in children. This risk increases as the dose of AG-Lisdexamfetamine increases. The healthcare professional will be monitoring the child’s height and weight while they are taking AG-Lisdexamfetamine. If the child is not growing or gaining weight as expected, the healthcare professional may stop AG-Lisdexamfetamine treatment.

Heart-related problems: The following heart-related problems have been reported in people taking medications to treat ADHD, like AG-Lisdexamfetamine:

• Sudden death in patients who have heart problems or heart defects;
• Stroke and heart attack in adults;
• Increased blood pressure and heart rate.

Sudden death has been reported in association with stimulant medicines for ADHD treatment in children and adolescents with structural heart abnormalities. AG-Lisdexamfetamine generally should not be used in children, adolescents or adults with known structural heart abnormalities. There may be additional heart-related risks if you are overweight or obese.

Tell your healthcare professional if you have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your healthcare professional will check:

• you for heart problems before starting AG-Lisdexamfetamine.
• your blood pressure and heart rate before and regularly during treatment with AG-Lisdexamfetamine.

Seek immediate medical help if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking AG-Lisdexamfetamine.

Mental health problems: The following mental health problems have been reported in people taking stimulant medicines like lisdexamfetamine dimesylate:

• New or worse thoughts or feelings related to suicide (thinking about or feeling like killing yourself) and suicidal actions (suicide attempt, suicidal ideation and completed suicide).
• New or worse symptoms of bipolar disorder (extreme mood swings, with periods of impulsiveness or unusual excitement, switching between periods of sadness).
• New or worse aggressive behaviour or hostility.
• New psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new mania (unusually excited, over-active or un-inhibited).

These new or worse mental symptoms may be more likely to occur if you have mental disorders that you may or may not know about. Tell your healthcare professional about any mental problems or about any personal or family history of suicide, bipolar illness, or depression you have.

A small number of patients taking ADHD medicines may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of suicide, self-harm or harm to others. Those suicidal thoughts or behaviours may occur at any time during treatment, particularly at the start or during dose changes, and also after stopping AG-Lisdexamfetamine. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your healthcare professional immediately. Close observation by a healthcare professional is necessary in this situation.

Serotonin toxicity (also known as serotonin syndrome): Serotonin toxicity is a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take AG-Lisdexamfetamine with certain antidepressants or migraine medications. Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Raynaud’s phenomenon (episodes of reduced blood flow): Stimulant medicines, such as AG-Lisdexamfetamine, are associated with Raynaud’s phenomenon. During treatment with AG-Lisdexamfetamine, your healthcare professional may check for problems with the circulation in your fingers and toes, including numbness, feeling cold or pain.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions

The following may also interact with AG-Lisdexamfetamine:

• other medications used to treat ADHD such as guanfacine.

• medicines used to treat depression or anxiety such as:

  • certain tricyclic antidepressants,
  • selective serotonin reuptake inhibitors (SSRIs), and
  • serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine.
• certain medicines used to treat migraines such as sumatriptan, rizatriptan or zolmitriptan.
• medicines used to manage psychotic symptoms such as pimozide, haloperidol and chlorpromazine.
• medicines that make urine more acidic such as ammonium chloride and sodium acid phosphate, as well as the dietary supplement ascorbic acid (vitamin C).
• medicines that make urine more alkaline such as sodium bicarbonate, acetazolamide, and thiazides.
• blood pressure medications or other medicines that can affect blood pressure such as beta blockers and norepinephrine.
• opioid medicines, used to relieve pain.
• lithium, used to treat manic episodes in bipolar disorder.
• modafinil, used to treat sleepiness due to narcolepsy.
• certain radioactive agents (used for diagnostic tests). This can cause false-positive test results and your healthcare professional may ask you to stop taking AG-Lisdexamfetamine for a short period before the diagnostic test.
• St John’s Wort, a herbal remedy.

How to take AG-Lisdexamfetamine:

• Take AG-Lisdexamfetamine once each day in the morning, with or without food.

• Avoid taking AG-Lisdexamfetamine in the afternoon as it may cause insomnia.

• If you were prescribed AG-Lisdexamfetamine capsules:

  • swallow the capsule whole with water; or
  • for patients with problems swallowing medicines, the capsule can be opened and all of the medication powder can be sprinkled over yogurt, water, or orange juice. Mix the medication powder thoroughly until the powder is completely dispersed. Make sure to break up any lumps of powder with a spoon. Eat the entire yogurt or drink all of the water or orange juice immediately. Do not store it for future use. Do not be alarmed if you see a film on the inside of the glass or container; this film contains non-medicinal ingredients. Do not divide the dose.
• As with all medicines, never share AG-Lisdexamfetamine with anyone else.

Usual dose:

• To treat Attention Deficit Hyperactivity Disorder (ADHD) (children 6 years of age or older, adolescents and adults):

  Your healthcare professional will decide the dose that is right for you. Always follow the directions of your healthcare professional and never change the dose or stop taking AG-Lisdexamfetamine without discussing it with your healthcare professional first.

  The usual dose is 20 mg to 60 mg once a day. Take AG-Lisdexamfetamine in the morning exactly as prescribed. Your healthcare professional may adjust the dose until it is right for you. The maximum daily dose is 60 mg.

  From time to time, your healthcare professional may interrupt your treatment to check your symptoms while you are not taking the medicine.

• To treat moderate to severe Binge Eating Disorder (BED) (adults):

  The recommended starting dose is 30 mg once a day in the morning. Your healthcare professional will then gradually increase your daily dose by 20 mg each week. They will do this until you’re taking 50 mg to 70 mg once a day in the morning. The maximum daily dose is 70 mg.

Overdose:

Missed dose:

If you forget to take your dose in the morning, wait until the next day and take the usual dose at the usual time in the morning. Do not take an afternoon dose. Do not double the dose to make up for the missed dose.

Possible side effects from using AG-Lisdexamfetamine:

These are not all the possible side effects you may have when taking AG-Lisdexamfetamine. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with AG-Lisdexamfetamine may include:

• headache, dizziness, feeling like your environment is moving or spinning (vertigo)
• dry mouth, decreased appetite, anorexia (eating disorder)
• trouble sleeping or falling asleep, feeling sleepy • upper abdominal pain, constipation or diarrhea, vomiting or nausea, indigestion
• numbness, or prickling or tingling sensations in the hands, arms, legs or feet
• fever, upper respiratory tract infection, stuffy nose or sore throat
• feeling irritable, anxious or jittery, lack or abundance of energy, rapid and sometimes exaggerated changes in mood
• decreased sex drive, inability to get or keep an erection
• bladder infection
• skin rash, hives, itchy skin
• ringing in the ears
• unusual dilation or widening of the pupils
• weight changes
• changes in taste
• excessive sweating
• nightmares
• clenching of teeth
• hair loss
• memory problems
• muscle aches and pain

Serious side effects and what to do about them

Only if severe In all cases

Common

Anxiety ✓ New or worsening tics: movements or

sounds that you cannot control

✓

Slowing of growth (height and weight) in

children

✓

Palpitation (fast-beating, fluttering or

pounding heart)

✓

Uncommon

Aggressive behaviour or hostility ✓ Allergic reaction: difficulty swallowing or

breathing, and throwing up, swelling of the

face, lips, tongue or throat, hives or rash

• Depression (sad mood that won’t go away):

difficulty sleeping or sleeping too much,

changes in appetite or weight, feelings of

worthlessness, guilt, regret, helplessness or

✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device- reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at 15 to 30°C. Protect from light.
• Keep out of reach and sight of children.

If you want more information about AG-Lisdexamfetamine:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-450-449-9272..